Systemic lupus erythematosus (SLE) is an autoimmune disease that can affect different systems and organs of the body and manifest with a wide spectrum of clinical symptoms. Lupus nephritis (LN) is one of the most severe manifestations of SLE; it is associated with increased morbidity and mortality. The drugs used to treat SLE and LN are largely old, generically available, and prescribed off-label. In 2011, Benlysta (IV) became the only drug approved for SLE in 60 years, but it is not labeled for patients with active LN and is not typically used in these patients. Thus, unmet need is high in this indication, leaving significant commercial opportunity for novel LN therapies.

The Unmet Need content provides quantitative insight into U.S. and European physician perceptions of key treatment drivers and goals and the current level of unmet need in LN. The analysis focuses on LN patients with International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III, IV, or V disease (either alone or in combination with III or IV) and excludes less severely ill patients (i.e., class I or II). We analyze the commercial opportunities in the LN therapy market and discuss how emerging therapies may capitalize on these opportunities.

Questions Answered:

  • What are the treatment drivers and goals for LN?
  • What drug attributes are key influences, which have limited impact, and which are hidden opportunities?
  • How do current therapies perform on key treatment drivers and goals for LN?
  • What are the prevailing areas of unmet need and opportunity in LN?
  • What trade-offs across different clinical attributes and prices are acceptable to U.S. and European rheumatologists for a hypothetical new LN drug?

Markets covered: United States, France, Germany, and United Kingdom

Primary research: Survey of 60 U.S. and 31 European rheumatologists fielded in December 2016

Key companies: Roche, Astellas Pharma, GlaxoSmithKline, Biogen, Bristol-Myers Squibb, Aurinia Pharmaceuticals

Key drugs: CellCept (mycophenolate mofetil), IV cyclophosphamide, tacrolimus, azathioprine, Rituxan/MabThera (rituximab), Benlysta (belimumab) [IV], Orencia (abatacept),  Orelvo (voclosporin)


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